search
Back to results

Evaluation of Dental Implants After Using Several Bone Splitting Techniques

Primary Purpose

Jaw, Edentulous

Status
Recruiting
Phase
Not Applicable
Locations
Syrian Arab Republic
Study Type
Interventional
Intervention
Osseodensification
Magnetic mallet
Piezo-surgery
Sponsored by
Damascus University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Jaw, Edentulous focused on measuring Osseodensification, Piezosurgery, Magnetic mallet

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Patients who can to follow-up appointments. Alveolar ridge width of at least 3 mm with sufficient height to place a regular implant. Availability of spongy bone with at least 1 mm in width between the cortical plates. Free of any underlying conditions that can impact bone metabolism. Exclusion Criteria: The presence of severe concavity on the vestibular or palatal side of the alveolar ridge. Patients with uncontrolled periodontal diseases. Patients who have undergone radiotherapy in the head and neck area. Smokers or patients with parafunction habits.

Sites / Locations

  • University of DamascusRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Osseodensification group:

Magnetic mallet group:

Piezo-surgery group

Arm Description

Ridge splitting by piezosurgery and osseodensification bur

Ridge splitting by piezosurgery and chisels by magnetic mallet

Ridge splitting by inserts of piezosurgery and bone expander

Outcomes

Primary Outcome Measures

The bone width gain
The change in bone width radiographically after ridge splitting. The radiographic measurement by using cone beam computed tomography.

Secondary Outcome Measures

Implant stability quotients
The score on a scale represents the degree of osseointegration and stability in dental implants by using MEGA Implant Stability Quotient. The scale ranges from 1 to 100, which indicates higher values meaning more excellent stability.

Full Information

First Posted
January 28, 2023
Last Updated
September 27, 2023
Sponsor
Damascus University
search

1. Study Identification

Unique Protocol Identification Number
NCT05720143
Brief Title
Evaluation of Dental Implants After Using Several Bone Splitting Techniques
Official Title
Evaluation of Clinical and Radiographic Outcomes of Immediate Dental Implants After Using Three Bone Splitting Techniques in Narrow Mandibular Alveolar Ridges: A Randomized Controlled Clinical Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 25, 2023 (Actual)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
January 12, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Damascus University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
In both full and partial tooth loss, the usage of dental implants for an artificial replacement for missing teeth is a well-known and reasonable treatment modality that leads to high patient satisfaction and enhanced life quality. (1) In both full and partial tooth loss, the usage of dental implants for an artificial replacement for missing teeth is a well-known and reasonable treatment modality that leads to high patient satisfaction and enhanced life quality Because there is insufficient bone volume to support the dimensions of the implants, the horizontal deficiencies of the alveolar ridge obstruct implant-supported rehabilitation, which has an impact on the ultimate prosthetic outcome from both a functional and cosmetic standpoint (2). The split crest technique reduces treatment time, the number of surgical procedures required, and even the risk of complications for the patients, making it more readily accepted by them. It also allows dental implants to be installed in the same surgical procedure and does not require a donor area to remove the graft. (3) In this study, patients underwent rehabilitation of posterior missing teeth in the narrow mandibular ridge by dental implant after ridge splitting by osseodensification, piezosurgery, or magnetic mallet.
Detailed Description
The study's objective is to compare ridge width gain after osseodensification, piezosurgery, or magnetic mallet after ridge splitting with simultaneous implant implantation in individuals with narrow alveolar ridges. 24 patients will be randomly allocated into three groups. Ridge splitting followed by piezo and bone expander will be performed with simultaneous implant placement in group 1. osseodensification bure will be performed after ridge splitting with simultaneous implant placement in group 2. magnetic mallet will be performed after ridge splitting with simultaneous implant placement in group 3.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Jaw, Edentulous
Keywords
Osseodensification, Piezosurgery, Magnetic mallet

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
Blinding Participant and Statistician
Allocation
Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Osseodensification group:
Arm Type
Experimental
Arm Description
Ridge splitting by piezosurgery and osseodensification bur
Arm Title
Magnetic mallet group:
Arm Type
Experimental
Arm Description
Ridge splitting by piezosurgery and chisels by magnetic mallet
Arm Title
Piezo-surgery group
Arm Type
Experimental
Arm Description
Ridge splitting by inserts of piezosurgery and bone expander
Intervention Type
Procedure
Intervention Name(s)
Osseodensification
Intervention Description
Procedure: the horizontal and vertical osteotomy will make by Piezo and bone splitting will do by osseodensification bur. After that Immediate implantation will be done.
Intervention Type
Procedure
Intervention Name(s)
Magnetic mallet
Intervention Description
Procedure: the horizontal and vertical osteotomy will do by Piezo and bone splitting will make by chisels of magnetic mallet. Immediate implantation will be done after splitting.
Intervention Type
Procedure
Intervention Name(s)
Piezo-surgery
Intervention Description
Procedure: the horizontal and vertical osteotomy will do by Piezo and bone splitting will make by inserts of piezosurgery and bone expander. Finally, immediate implantation will be placed.
Primary Outcome Measure Information:
Title
The bone width gain
Description
The change in bone width radiographically after ridge splitting. The radiographic measurement by using cone beam computed tomography.
Time Frame
(Time Frame: Baseline, immediately after surgery, and after 4 months of surgery)
Secondary Outcome Measure Information:
Title
Implant stability quotients
Description
The score on a scale represents the degree of osseointegration and stability in dental implants by using MEGA Implant Stability Quotient. The scale ranges from 1 to 100, which indicates higher values meaning more excellent stability.
Time Frame
(Time Frame: at the time of surgery and 4 months after surgery)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients who can to follow-up appointments. Alveolar ridge width of at least 3 mm with sufficient height to place a regular implant. Availability of spongy bone with at least 1 mm in width between the cortical plates. Free of any underlying conditions that can impact bone metabolism. Exclusion Criteria: The presence of severe concavity on the vestibular or palatal side of the alveolar ridge. Patients with uncontrolled periodontal diseases. Patients who have undergone radiotherapy in the head and neck area. Smokers or patients with parafunction habits.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ِِِِAhmad Albassal, Master degree in OMFS
Phone
0994391848
Email
dr.ahmad.bassal.91@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Munir Harfouch, PHD in OMFS
Phone
0933567716
Email
prof.munirharfouch@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmad Albassal, Master degree in OMFS
Organizational Affiliation
Department of Oral and Maxillofacial Surgery, University of Damascus Faculty of Dentistry, Damascus
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Munir Harfouch, PHD in OMFS
Organizational Affiliation
Department of Oral and Maxillofacial Surgery, University of Damascus Faculty of Dentistry, Damascus
Official's Role
Study Director
Facility Information:
Facility Name
University of Damascus
City
Damascus
Country
Syrian Arab Republic
Individual Site Status
Recruiting

12. IPD Sharing Statement

Citations:
PubMed Identifier
26800171
Citation
Pozzi A, Mura P. Immediate Loading of Conical Connection Implants: Up-to-2-Year Retrospective Clinical and Radiologic Study. Int J Oral Maxillofac Implants. 2016 Jan-Feb;31(1):142-52. doi: 10.11607/jomi.4061.
Results Reference
background
PubMed Identifier
16968389
Citation
Chiapasco M, Zaniboni M, Boisco M. Augmentation procedures for the rehabilitation of deficient edentulous ridges with oral implants. Clin Oral Implants Res. 2006 Oct;17 Suppl 2:136-59. doi: 10.1111/j.1600-0501.2006.01357.x.
Results Reference
background
PubMed Identifier
25586966
Citation
Bassetti MA, Bassetti RG, Bosshardt DD. The alveolar ridge splitting/expansion technique: a systematic review. Clin Oral Implants Res. 2016 Mar;27(3):310-24. doi: 10.1111/clr.12537. Epub 2015 Jan 14.
Results Reference
background
PubMed Identifier
9586460
Citation
Buser D, Mericske-Stern R, Bernard JP, Behneke A, Behneke N, Hirt HP, Belser UC, Lang NP. Long-term evaluation of non-submerged ITI implants. Part 1: 8-year life table analysis of a prospective multi-center study with 2359 implants. Clin Oral Implants Res. 1997 Jun;8(3):161-72. doi: 10.1034/j.1600-0501.1997.080302.x.
Results Reference
background
PubMed Identifier
11952734
Citation
Cochran DL, Buser D, ten Bruggenkate CM, Weingart D, Taylor TM, Bernard JP, Peters F, Simpson JP. The use of reduced healing times on ITI implants with a sandblasted and acid-etched (SLA) surface: early results from clinical trials on ITI SLA implants. Clin Oral Implants Res. 2002 Apr;13(2):144-53. doi: 10.1034/j.1600-0501.2002.130204.x.
Results Reference
background

Learn more about this trial

Evaluation of Dental Implants After Using Several Bone Splitting Techniques

We'll reach out to this number within 24 hrs